TFS HealthScience

Role Description As part of our CDS Therapeutic area / Ophthalmology team, you will work alongside passionate and innovative professionals to ensure our customers achieve their goals. The Trial Master File Lead is responsible for organizing, maintaining, and overseeing the Trial Master File (TMF) according to company policies, SOPs, Work Instructions, regulatory requirements, PM delegation, and coordinating main tasks under TMF Business Line. This role may act as Line Manager for TMF Associates. - Create the Study TMF EDL in cooperation with PM (Project Manager) and study team. - Create the first draft of TMF Plan, implement changes after review, generate final version, and distribute final version to the study team. - Create TMF at Trial, Country, and Site Level (paper TMF). - Control if the Electronic Trial Master File (eTMF) at Trial, Country, and Site Level was properly created by Clinical Business Administrator (CBA) team when TFS system is used. - Inform the study team that TMF is created and ready for document upload for eTMF or submission to paper TMF (pTMF). - Actively follow up with the study team to ensure documentation is submitted following the process described in The TMF Plan and that the TMF is always audit and inspection ready. - Set up the Investigator’s File as directed by Clinical Research Manager (CRM) and forward the CRM a tracker of all document sections within the ISF. This activity may be delegated to TMF A and/or Project Management Associate (PMA) depending upon study needs. - Actively collaborate in the training of the study team regarding the TMF workflow and management. - Act as contact person for the study team to support TMF doubts or TMF issues and ensure TMF is always inspection ready. - Maintain and follow up TMF status, identify areas with missing documentation and inconsistencies, and follow up with the study team for resolution. - Perform Quality Check of each document before filing in TMF and follow up issues until resolution. - Perform Quality Check of each uploaded document after filing in eTMF and follow up issues until resolution. - Responsible for creating and maintaining paper TMF (pTMF) tracker and generating reports for eTMF. - Generate metrics supporting TMF completeness and accuracy. Qualifications - 5 and above years of proven relevant experience in Clinical Trials with TMF management including oversight and quality control. - Deep knowledge of GCP/ICH guidelines. - Strong understanding of the impact of the TMF on Study management. - Strong written and communication skills and demonstrate ability to communicate and coordinate within the group of TMF stakeholders. - At least 1 year of proven people management. Benefits - Competitive compensation package. - Comprehensive benefits. - Opportunity for personal and professional growth in a rewarding environment. - Joining a team that values collaboration, innovation, and making a difference in the lives of patients. Company Description Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. - Core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decision-making. - High employee engagement and satisfaction through alignment on fundamental values. - Fostering a culture of mutual respect and collaboration.

Role Description Join Our Team as a Trial Master File Associate (1 FTE) - (home based in EU). As part of our CDS Ophthalmology team, you will work alongside passionate and innovative professionals to ensure our customers achieve their goals. The Trial Master File Associate (TMF Associate) is part of the TMF Delivery Business Line within Clinical Development Services (CDS) and will function operationally as a member of the Study Team with the responsibility to organize, maintain, and oversee the Trial Master File (TMF) according to company policies, SOPs, Work Instructions, regulatory requirements, TMF Functional Lead, and PM delegation. Key Responsibilities - Notify study team that TMF is created and ready for document upload for eTMF or submission to pTMF. - Develop TMF Plan. - Provide training on study specific TMF requirements, guidelines including TMF Plan. - Perform QC2 on documents and documents reconciliation. - Provide TMF Monthly Reports to PM, Line manager, and Head of TMF Delivery. - Regularly check TMF metrics, follow up on detected issues, ensure acceptable level of metrics. - Ensure TMF processes timely implementation and execution. - Adjust study specific TMF Index/EDL in the relevant files/system as directed by the PM (Project Manager). - Ensure valid forms and templates are implemented and maintained in the assigned projects. - Check status of duplicates, documents in error, size and path length (if applicable), follow up on necessary corrections accordingly. - Coordinate Monthly and Quarterly TMF Reconciliation by creating Action Plan and submitting relevant report on the status. - Ensure TMF AoR completion and monitoring TMF transfer/shipment to the Sponsor. - Ensure delivery of fully executed TMF AoR to TMF Functional lead. - Actively follow up that the study team is submitting documentation, EDL maintenance for eTMF in cooperation with study team, following the process described in The TMF Plan and that the TMF is always submission and inspection ready. Qualifications - At least 1-5 years of experience in CRO or Pharmaceutical Industry with proven TMF Management. - Bachelor’s Degree in Health Science or Document Management or equivalent work experience is preferred. - Knowledge of GCP/ICH guidelines. - Good written and communication skills. - Good organizational and multi-tasking skills. - Good software and computer skills. Benefits - We provide a competitive compensation package. - Comprehensive benefits. - Opportunity for personal and professional growth in a rewarding environment. - Join a team that values collaboration, innovation, and making a difference in the lives of patients. Company Description Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.

Role Description TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions. Key Responsibilities - EU‑QPPV Responsibilities (≈10 hours/month) - Act as EU Qualified Person for Pharmacovigilance (EU‑QPPV) with ultimate responsibility for the EU Pharmacovigilance System. - Ensure the EU PV System is adequately established, maintained and compliant with applicable GVP modules and EU pharmacovigilance legislation. - Ensure the accuracy, completeness, consistency and continuous availability of the Pharmacovigilance System Master File (PSMF). - Provide oversight of: - Safety reporting and ICSR management - Signal detection and signal management activities - Risk Management Plans (RMPs) and risk minimization measures - Act as the primary pharmacovigilance contact with EMA and EU National Competent Authorities (NCAs). - Lead and support regulatory inspections, audits and compliance activities, including CAPA follow‑up. - Ensure permanent and appropriate EU‑wide pharmacovigilance oversight and governance. - Spanish Deputy QPPV Responsibilities (≈5 hours/month) - Act as Deputy Local Qualified Person for Pharmacovigilance (Deputy LQPPV) in Spain. - Support the LQPPV and ensure 24/7 local pharmacovigilance availability for the Spanish Agency of Medicines and Medical Devices (AEMPS). - Manage and escalate local Spanish safety cases in alignment with national and EU requirements. - Support compliance with Spanish pharmacovigilance legislation and local reporting obligations. - Assist with local pharmacovigilance inspections, audits and regulatory follow‑up activities. - Local Literature Monitoring – Spain (≈10 hours/month) - Perform weekly screening of Spanish and local medical and scientific literature. - Identify Individual Case Safety Reports (ICSRs) and potential safety signals. - Ensure findings are reported within regulatory timelines. - Maintain complete, traceable and inspection‑ready documentation in compliance with GVP requirements. Qualifications - Bachelor’s Degree, preferably in life science or nursing; or equivalent. - 10 years of relevant experience including management of large safety teams. - Able to work in a fast-paced environment with changing priorities. - Understand the medical terminology and science associated with the assigned drugs and therapeutic areas. - Understanding of the Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation and internal SOPs. - Ability to work independently as well as in a team matrix organization with little or no supervision. - Excellent written and verbal communication skills. - Demonstrate proficiency using typical word processing; spreadsheets desirable; and presentation software a plus. Benefits - We provide opportunities for personal and professional growth in a rewarding environment. - You will join a team that values collaboration, quality, and making a difference in the lives of patients. - Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. - By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. - Together, we make a difference.

Role Description TFS HealthScience is seeking an experienced Medical Monitor (MM) to support a Phase 2a clinical study across multiple European sites. The role provides medical oversight and 24/7 on-call coverage from study start-up through close-out. This is a part-time engagement (up to 0.3 FTE), offered through our Strategic Resource Solutions (SRS) model. - Provide medical oversight and 24/7 on-call medical coverage for investigator sites - Review and assess SAEs, protocol deviations, and eligibility queries - Support protocol interpretation, medical review of clinical data, and safety monitoring - Partner with the sponsor and clinical operations team on medical and scientific questions - Contribute to safety reporting and medical sections of clinical documents - Train site staff on protocol-specific medical questions where required Qualifications - Medical degree (MD) with active medical license - Prior experience as Medical Monitor on interventional clinical trials - Experience in rare disease and/or relevant therapeutic areas an advantage - Familiarity with ICH-GCP, EU CTR, and pharmacovigilance requirements - Based in Europe; able to support 24/7 coverage - Fluent English; additional European languages an asset Benefits - Opportunities for personal and professional growth in a rewarding environment - Join a team that values collaboration, quality, and making a difference in the lives of patients - Core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture - Foster collaboration, innovation, and a shared commitment to excellence Company Description Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Role Description TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical company that is an industry leader within its therapeutic area. - Deliver and implement advanced secondary analyses of EMR and claims data to support observational epidemiological studies. - Design and execute analyses for real-world observational studies with no intervention. - Provide expert input and recommendations on study design, data partner selection, and Real-World Data (RWD) best practices. - Collaborate with internal and external teams to evaluate the strengths and limitations of RWD sources for respiratory research. - Independently design and build analytical solutions for complex healthcare datasets. - Develop, validate, and document analytical methods and models using SQL (required), R, and Python. - Apply advanced statistical methods (e.g., regression models, Cox regression, Kaplan-Meier survival analysis) to generate robust insights. - Contribute to study reports, publications, and presentations through high-quality statistical analyses and visualizations. Qualifications - Master’s degree in Statistics, Mathematics, Data Science, or a related Life Sciences discipline. - Demonstrated experience with large datasets, preferably healthcare data. - Excellent SQL skills and strong experience querying complex databases. - Excellent programming skills in R; Python experience is an advantage. - Strong problem-solving skills and ability to independently develop analytical solutions. - Good understanding of statistical methods used in observational research (e.g., regression, Cox regression, Kaplan-Meier). - Experience working with observational studies with no intervention. - Familiarity with ADaM/SDTM datasets and clinical data structures. - Experience working with or understanding of the OMOP Common Data Model (OMOP CDM). - Experience with Imaging Data (CT scan reading in particular) - a must-have. Benefits - Opportunities for personal and professional growth in a rewarding environment. - A team that values collaboration, quality, and making a difference in the lives of patients. - Core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. - Fostering collaboration, innovation, and a shared commitment to excellence. Company Description Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Role Description As part of our CDS Ophthalmology team, you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals. The Senior Project Manager will have the overall responsibility for managing projects in accordance with company policies, SOPs, regulatory requirements in addition to financial and contractual obligations. - Ensure that projects are delivered on-time, within scope and within budget and in compliance with applicable quality standards. - Manage the strategic aspects of projects and identify, analyze, and minimize/mitigate any risk, including the implications of different technical and operational choices. - Communicate effectively with clients to successfully manage the relationship, identify needs, and evaluate alternative business solutions and strategies. - Develop and maintain Project Plans and timelines for their project and track progress. - Work with the Finance & Accounting team to analyze profitability, revenue, margins, and utilization across their projects. - Manage resource allocation on the project, in collaboration with respective line managers. Qualifications - Bachelor’s Degree, preferably in life science. - 5 years of experience working as Global Sr Project Manager. - In-depth experience working with Phase III studies. - Experience in vendor management. - Experience with global budgets. - Experience in sponsor communication. - Experience in ophthalmology and CRO experience is a big plus. Benefits - Competitive compensation package. - Comprehensive benefits. - Opportunity for personal and professional growth in a rewarding environment. - Joining a team that values collaboration, innovation, and making a difference in the lives of patients. Company Description Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific, and the Middle East. - Core values of Trust, Quality, Flexibility, and Passion. - Values shape our culture and work ethic. - Reflect what we stand for and guide our organization. #Together we make a difference

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description We are seeking an experienced and results-driven Senior Director Business Development to join our North American Clinical Development Services (CDS) Internal Medicine and Neurology team. In this role, you will collaborate with a highly skilled and motivated group of professionals, driving new partnerships and expanding our presence in the U.S. market. As Senior Director Business Development - IMN (Internal Medicine and Neurology), you will be responsible for strategic sales planning, client relationship management and overall growth of CDS. You will work cross-functionally with internal teams to ensure seamless support for new and existing clients. Key Responsibilities - Develop and execute a business development strategy focused on the North American biotech/pharma market - Drive new business acquisition to meet or exceed annual sales targets - Identify and qualify new leads, managing the full sales lifecycle from initial outreach to contract negotiation - Collaborate with internal teams to respond to Requests for Information (RFIs) and Requests for Proposals (RFPs) - Prepare TFS teams for client engagements, including Capabilities Presentations and Bid Defense Meetings (BDMs) - Manage contract and budget discussions post-award to ensure alignment and client satisfaction - Establish and maintain strong relationships with prospective and current clients - Organize and deliver high-quality sponsor presentations that communicate the value of TFS’ CDS services - Provide strategic input and leadership during proposal development - Monitor project status post-award and coordinate scope changes as needed - Track competitive intelligence and market trends in the CRO space - Represent TFS at industry conferences and tradeshows in North America - Manage travel and expense reporting in compliance with company guidelines Qualifications - Bachelor’s Degree or equivalent relevant experience - Minimum of 5 years of experience in clinical research, business development, or sales within the CRO industry - Proven track record of at least 3 years in consultative sales with strong negotiation and closing skills - Strong communication skills with the ability to engage and influence clients and stakeholders at all levels - Deep understanding of clinical development and the regulatory landscape in the U.S. - Strong organizational skills, self-starter, and comfortable working independently in a remote environment - Experience with CRM tools and Microsoft Office Suite - Excellent presentation and proposal development skills - Willingness to travel across North America to attend client meetings, conferences and internal events as needed Benefits - Competitive compensation package - Comprehensive benefits - Opportunity for personal and professional growth in a rewarding environment - Team that values collaboration, innovation, and making a difference in the lives of patients

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description We are seeking an experienced and results-driven Senior Director Business Development to join our North American Clinical Development Services (CDS) DIID (Dermatology, Immunology & Inflammatory Diseases) team. In this role, you will collaborate with a highly skilled and motivated group of professionals, driving new partnerships and expanding our presence in the U.S. market. - Develop and execute a business development strategy focused on the North American biotech/pharma market - Drive new business acquisition to meet or exceed annual sales targets - Identify and qualify new leads, managing the full sales lifecycle from initial outreach to contract negotiation - Collaborate with internal teams to respond to Requests for Information (RFIs) and Requests for Proposals (RFPs) - Prepare TFS teams for client engagements, including Capabilities Presentations and Bid Defense Meetings (BDMs) - Manage contract and budget discussions post-award to ensure alignment and client satisfaction - Establish and maintain strong relationships with prospective and current clients - Organize and deliver high-quality sponsor presentations that communicate the value of TFS’ CDS services - Provide strategic input and leadership during proposal development - Monitor project status post-award and coordinate scope changes as needed - Track competitive intelligence and market trends in the CRO space - Represent TFS at industry conferences and tradeshows in North America - Manage travel and expense reporting in compliance with company guidelines Qualifications - Bachelor’s Degree or equivalent relevant experience - Minimum of 5 years of experience in clinical research, business development, or sales within the CRO industry - Proven track record of at least 3 years in consultative sales with strong negotiation and closing skills - Strong communication skills with the ability to engage and influence clients and stakeholders at all levels - Deep understanding of clinical development and the regulatory landscape in the U.S. - Strong organizational skills, self-starter, and comfortable working independently in a remote environment - Experience with CRM tools and Microsoft Office Suite - Excellent presentation and proposal development skills - Willingness to travel across North America to attend client meetings, conferences and internal events as needed Benefits - We provide a competitive salary and performance-based incentives - Comprehensive benefits - Opportunity for personal and professional growth in a rewarding, global environment - Remote work flexibility - Collaborative, mission-driven environment focused on patient outcomes and clinical innovation